Wired News – Clearside BioMedical Reported Positive Top-line Results from Phase-3 Trial Assessing CLS-TA in Macular Edema Associated with Non-infectious Uveitis

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LONDON, UK / ACCESSWIRE / March 07, 2018 / Active-Investors.com has just released a free research report on Clearside BioMedical, Inc. (NASDAQ: CLSD) (“Clearside”). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=CLSD as the Company’s latest news hit the wire. On March 05, 2018, the Company announced positive top-line results from its pivotal Phase-3 clinical trial, PEACHTREE, evaluating the safety and efficacy of CLS-TA for suprachoroidal administration (suprachoroidal CLS-TA) in patients with macular edema associated with non-infectious uveitis. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Clearside BioMedical most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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PEACHTREE Trial and Results

Clearside enrolled 160 patients with macular edema associated with non-infectious uveitis in PEACHTREE, a randomized, masked, sham-controlled Phase-3 trial. 96 patients were randomized to receive two 4 mg doses of suprachoroidal CLS-TA 12 weeks apart, and 64 patients were randomized to undergo sham (placebo) procedures at the same 12-week interval. Patients were evaluated every four weeks for a total of 24 weeks. A total of 155 patients completed the full evaluation period of the trial. The primary endpoint measure was the proportion of patients achieving at least 15 letters improvement in BCVA (best corrected visual acuity) using the ETDRS (Early Treatment of Diabetic Retinopathy Study) scale at 24 weeks.

47% of patients who received suprachoroidal CLS-TA every 12 weeks gained at least 15 letters in BCVA, as measured using the ETDRS scale, at week 24, compared to 16% of patients who underwent a sham procedure. This improvement, which was the primary endpoint of the trial, was statistically significant. Suprachoroidal CLS-TA was well tolerated, with no treatment-related serious adverse events reported in the trial. Detailed results from PEACHTREE will be presented at an upcoming medical conference.

Clearside to Submit a New Drug Application for Suprachoroidal CLS-TA to FDA in Q4 2018

Daniel H. White, Chief Executive Officer and President of Clearside, stated that having nearly 50% of the PEACHTREE trial patients treated with suprachoroidal CLS-TA gain 15 or more letters in vision is highly compelling.

Daniel added that currently the Company expects to submit a new drug application for suprachoroidal CLS-TA in patients with macular edema associated with uveitis to the FDA in the fourth quarter of 2018, and Clearside is also evaluating a number of options for submissions to regulatory agencies in additional territories outside of the United States.

Reports suggest that post announcement of the news, the shares of Clearside surged over 50% in premarket trade.

About Uveitis

Uveitis is the inflammation of the uvea. It is one the world’s leading causes of blindness. The uvea consists of the middle layer of pigmented vascular structures of the eye that lies between the inner retina and the outer fibrous layer composed of the sclera and cornea. Uveitis does not cause mortality but morbidity results from chronic swelling in the retina (macular edema) that leads to damage to the structures of the eye, including the retina and the lens (cataracts) and complications from medications. Most common treatments of uveitis include corticosteroids and other immunomodulators.

About Suprachoroidal CLS-TA

Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS™, which is the space located between the choroid and the outer protective layer of the eye known as the sclera. Suprachoroidal CLS-TA, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline of treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the retina and the choroid.

About Clearside BioMedical, Inc.

Founded in 2011 and headquartered in Alpharetta, Georgia, Clearside Biomedical is a late-stage clinical ophthalmic biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases. The Company relentlessly pursues transformative, elegant, precise solutions to restore and preserve vision.

Stock Performance Snapshot

March 06, 2018 – At Tuesday’s closing bell, Clearside BioMedical’s stock surged 25.36%, ending the trading session at $12.95.

Volume traded for the day: 8.15 million shares, which was above the 3-month average volume of 424.48 thousand shares.

Stock performance in the last month – up 110.23%; previous three-month period – up 85.00%; past twelve-month period – up 67.96%; and year-to-date – up 85.00%

After yesterday’s close, Clearside BioMedical’s market cap was at $328.14 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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